Royal Commission on Environmental Pollution

On 24 October 2001, the Royal Commission sent the following letter to over two hundred organisations and individuals. The Commission would welcome written information from any other body or individual who wishes to submit views on the is22 March, 2007 href="#letter">Invitation to submit evidence
           Annex A - Background to the Study
           Annex B - Issues of particular interest
           Annex C - List of organisations and individuals contacted

ROYAL COMMISSION STUDY ON LONG-TERM EFFECTS OF CHEMICALS IN THE ENVIRONMENT - INVITATION TO SUBMIT EVIDENCE

The Commission announced its intention to study the long-term effects of chemicals in the environment in October 2000. Since then, it has been scoping the Study. A summary of the work carried out during the scoping phase, with more background on the Study is attached at annex A. The Commission is now ready to begin the Study in earnest.

The central aim of the Study is to analyse the key issues and make recommendations designed to reduce the chance that chemical use will cause long-term damage to the natural environment or human health. To help with this task, you are invited to submit evidence on the Study. A list of issues upon which the Commission is particularly interested in receiving evidence is attached at annex B. This consists of a series of underpinning assumptions, followed by a menu of possible guiding principles that could be adopted, concluding with more detailed questions on chemical assessment and control.

The deadline for responses is 1 February 2002.

It would be appreciated if, where possible, submissions could be sent by e-mail to john.rea@rcep.org.uk . Printed reports and references can be sent separately by post.

You do not need to address all the issues listed; indeed, you may feel that you can provide useful evidence on only a few. It will be helpful to the Secretariat if you can use the numbering given in annex B to indicate which of the issues each section of your response addresses. You may wish to go beyond the attached list of issues. If so, or if you have any queries on what the Commission is seeking, please contact me at the above number.

While the Commission is always interested in opinions of interested parties on the topics it studies, you should bear in mind that the principal goal of this invitation is to elicit responses drawing the Commission's attention to documentary evidence or argument to support particular views.

Shorter, informal submissions can also be made by posting messages on our website discussion forum at http://www.rcep.org.uk/chemicals where you can also respond to other postings. The discussion forum has been reconfigured to make it easier to use and I hope that you will find it a useful means of exchanging views on chemical issues, as well as making contributions to the Commission's Study.

Unless indicated otherwise when evidence is submitted, it will be assumed that the organisation or individual submitting it has no objection to its disclosure to other parties should the Commission so decide. The most likely method of such dissemination is through publication on the Commission's website.

This letter has been sent to a wide range of stakeholders and interested parties (listed in annex C), and has been posted on the Commission's website. If you think that we have missed any individual or organisation that might like to contribute, feel free to either contact me or pass a copy on to them directly.

I look forward to hearing from you.

Yours faithfully,

John Rea
Assistant Secretary to the Commission

ANNEX A

Background to the Royal Commission's Study on the Long-term Effects of Chemicals in the Environment ('the Chemicals Study')

The Royal Commission

The Royal Commission is an independent standing body established by royal warrant in 1970 to provide advice on environmental issues. Its primary role is to contribute to policy development in the longer term by providing an authoritative factual basis for policy-making and debate, and setting new policy agendas and priorities. In reaching its conclusions, the Commission seeks to make a balanced assessment, taking account of the wider implications for society of any measures proposed.

The Chemicals Study

The developments in the chemical industry during the last 150 years have brought spectacular benefits to mankind. On the other hand, the manufacture and use of chemicals creates risks to the natural environment and humans, many of which are poorly characterised. There is a long history of chemicals that were originally thought to be purely beneficial turning out to have adverse effects on the natural environment, ecosystems, and human health as a result of their release: for example DDT and the decline of raptor populations as a result of egg shell thinning; PCBs and reproductive effects in humans and other vertebrates; and CFCs and the ozone layer.

Despite a large, and rapidly growing, national and international effort to assess the effects of chemicals in the environment, major doubts persist as to the effectiveness of present policies in protecting the health of both humans and ecosystems from unintended long-term effects. This concern needs to be balanced against the benefits of chemicals to society.

The Commission decided to address this issue and announced its intention to do so in October 2000. The central aim of the Study is to analyse the key issues and make recommendations designed to reduce the chance that chemical use will cause long-term damage to the natural environment, or human health from exposure mediated by the environment.

The invitation to submit written evidence on key issues marks the formal start of the Study. The Commission will build upon the evidence it receives with a series of meetings with key stakeholders (some in the form of oral evidence sessions), visits and consideration of papers produced by its Secretariat. The report is due to be published in mid-2003.

The Announcement of the Study

The Commission's announcement identified three major themes:

• Scientific knowledge and further research needs;
• How chemicals are best assessed and potential hazards and risks identified;
• The principles that should be followed in regulating the production and use of chemicals.

The full text of the original announcement of the Study can be found on the Commission's web site at: http://www.rcep.org.uk/chemicals.htm

The Commission has received and considered 44 responses to the announcement of the Study (also available on the it's website). As a result it has decided not to limit the types of chemicals covered by the Study, provided they are traded, or incorporated into products, or are substances that derive from such activities. The primary focus will be on how decisions are taken about their use and/or control. While the Commission may wish to use case studies to illustrate various points, individual chemicals and their uses are not the primary focus.

The Commission Working Group

There are many challenges posed by the Study. A Commission working group has considered some of the issues raised by the current state of scientific knowledge and risk assessment techniques. Its interim conclusions are that:

• Ignorance outweighs knowledge at every point in the assessment process;
• Only a small fraction of industrially produced chemicals have been studied in any depth, and, even then;
• The estimates of environmental exposure and effect are subject to large uncertainty and indeterminacy.

It has been suggested that reassurance can be derived from experience - health and longevity have improved despite exposure to a wide variety of chemicals; but this could be attributed to an absence of evidence of subtle, but potentially important effects, rather than evidence of their absence. There are many historical examples, from ozone depletion to endocrine disruption, where unexpected effects have been discovered and it would be naïve to think that our current understanding precludes further surprises.

The Working Group believes that further research and testing are at best only partial solutions to the problem and has identified several aspects to the problem facing those who wish to demonstrate chemical safety:

• Firstly, there is the sheer number of chemicals. Depending on which definition you use, there are between 30,000 and 100,000 chemicals on the market in some shape or form in greater than laboratory scale quantities (with several hundred new substances added every year). Of these, less than 5% are approved for specific uses such as food additives, pesticides, biocides or pharmaceuticals. Negative lists largely control the rest, i.e. it can be used unless specifically regulated against. Some 10,000 chemicals are used in quantities over 10t/a, with of the order of 2,000 produced in quantities in excess of 1,000t/a (defined as high production volume chemicals, or HPVCs). They are used in a multitude of ways: many are building block chemicals that are used to make other products; others are incorporated into formulations or products that are then used in other industries or sold to the public. They may consist of pure individual chemicals, or complex mixtures.
• The second problem is the distinct lack of reliable data for the vast majority of these chemicals. The EC Existing Substances Regulation has begun risk assessments on less than 200 of the HPVCs. The recent EC White Paper on Chemicals is an indication that this process has failed, but the Royal Commission is far from convinced that the proposed solutions (essentially more of the same) are either practical or adequate. The proposals will no doubt result in a huge increase in the data available for the assessments, albeit at huge cost in terms of both money and animals.
• However, the third major problem, uncertainties in the risk assessment process itself, will remain, as will the long debates on costs and benefits of individual risk management proposals. Risk assessment involves comparing 'no effect' levels with exposure estimates for a variety of "realistic worst case" scenarios, derived from a dataset on an individual chemical. This aims to identify potential problems before they become apparent in the environment. Many of the presentations that the Working Group has received have indicated areas of ignorance and uncertainty in: data reliability; the validity of risk assessment assumptions; and basic understanding of environmental processes and effects.

Producers of industrial chemicals, who are responsible for the submission of datasets to the regulators, often do not know how or where their chemicals are incorporated into products, the conditions under which these are used, and their potential for release through use or disposal. Supply chains may be long and can be shrouded in commercial secrecy.

Modelling the fate and transport of a substance in the environment is plainly difficult. Transport in the atmosphere or in water can lead to limited regions of high concentration rather than uniform dilution. There are many ways in which a chemical may break down, with each process dependent on a variety of environmental factors. Poorly understood bioaccumulation and food chain processes further confuse the exposure picture. Many of these processes can be modelled, but the models are severely limited by either lack of data, or variation in those that are available.

There is insufficient monitoring of both the state of environmental systems, which might provide early warnings of problems, and the broad sweep of substances to be found in the environment. Monitoring of chemicals in the environment in the UK and elsewhere tends to focus on well-known, heavily regulated pollutants. Often, where measurements do exist, they have not been made in the media where the highest levels of the target substance would be expected. In any case, risk assessment finds it difficult to incorporate monitoring results.

The calculation of environmental 'no effect concentrations' also includes large uncertainties. A handful of standard test methods are available to test toxicity to environmental species. The results of these tests are extrapolated to produce an estimate of levels that might cause effects in the environment. To do this, assumptions have to be made about the reliability and reproducibility of the test methods and the relationships between: the sensitivity of the species, life-stage and sex tested and that of all other species; the laboratory and environmental conditions; acute and chronic exposure; and inter- and intra-species effects. It is generally assumed that effects are only additive, and not synergistic. This is likely to be reasonable for most substances, but probably not for all (and nobody knows which these might be).

Most chemicals have little or no interpretable toxicity data. The ability to predict human or environmental toxicity without recourse to animal or tissue experiments seems very limited at the moment. Quantitative Structure Activity Relationships (QSARs) and rule-based expert systems might be useful for priority setting, but they seem too unreliable and limited in application to provide any real help in risk assessment. In vitro test methods exist for only a few endpoints and there seems little prospect of any dramatic shift away from in vivo testing, without acceptance of much greater uncertainty in the assessment of adverse human effects.

There is also the question of whether the standard toxicity tests are able to measure endpoints of concern. Endocrine disruption effects arising from environmental chemical exposure is an example of an effect that could not be picked up by the current standard chemical assessment dataset. In this case, as in several other infamous environmental effects arising from chemical exposure, the alarm was raised by observations in the environment, rather than predictions from chemical datasets. Even in cases where there is strong scientific evidence linking the use of particular chemicals to environmental harm, there has been a very slow policy response to the threat, often measured in decades.

Comments on the EU Review of Chemicals Policy

Members have considered the European Commission's recent White Paper on Chemicals, and responded to consultations from DETR and a Parliamentary Select Committee on the issues it raises. The main points of the responses were concerns over the effectiveness and feasibility of the proposals, the implications for animal testing, the lack of public involvement in the process, and the need to consider alternative approaches to determining chemical safety. The Commission awaits the Select Committee's report with interest and will take their findings into account during its own Study.

Literature Review of Chemicals and People's Values

Consultants at the University of Edinburgh have undertaken a literature review on behalf of the Commission. This showed that there are relatively few independently researched studies on people's values with respect to chemicals. Those that do exist show that public perception of the chemical industry and its products has been in a slow but steady decline, and is so poor that there is a risk of sudden public reaction to minor events due to social amplification. The authors concluded that there is a need to find mechanisms for accommodating interest-based and value-based positions in policy and regulatory decision-making.

Royal Commission Seminar

The Commission held a seminar on 'Fresh Approaches to Chemical Use and Control' on 19 July 2001 involving representatives from a wide variety of interested parties.

There seems a general acceptance that the current system of assessing and controlling risks is unsatisfactory. However, there is a broad spectrum of views as to what should be done about it. These views can be broadly separated into three strands:

• Mainstream opinion takes the view that current initiatives, such as the EC White Paper and the industry's own 'Confidence in Chemicals' programme, can address the public's concerns, based on an increase in the amount of information on chemicals and a process of risk assessment. Authorisation might be required for some chemicals, but that would prove to be the exception rather than the rule.
• A second, more radical view is that the lack of knowledge on chemicals and their effects demands a more precautionary approach, with most chemicals subject to authorisation based on a strict enforcement of data requirements, and a commitment to substituting or eliminating hazardous chemicals wherever possible. This strand would have the debate focus on the societal need for the service provided by chemicals rather than the individual chemicals themselves. Control could be on the basis of hazard, rather than risk, since effects are so poorly understood and exposure so poorly controlled.
• There is a contrary view that the risks to health and the natural environment from chemicals are outweighed by the effects on social and economic development caused by the attempts to address those risks; that the culture of deference to authority has been replaced by a debilitating culture of fear that will stifle human progress. This viewpoint would seek to increase the amount of information on chemicals, but only control when effects have been positively identified in the environment.

Among the issues raised at the seminar were:

• The need for a much greater awareness of what chemicals are contained in products;
• The potential for consumers to drive the process through commercial pressures on retailers;
• The potential dangers to the economically important UK chemicals sector from measures which could damage its competitiveness;
• The potential for chemicals issues to parallel the public reaction to GM products through social amplification;
• The potential for monitoring of chemical and biological endpoints to play a much enhanced role in regulatory decisions;
• The need for greater effort to develop and validate non-animal testing methods;
• The dividing lines between science and values in the risk assessment and management process.

A fuller summary of the issues raised is available on the Commission's website.